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04 Oct 2024
Admin
News Article

Dr Reddy’s Inks Voluntary Licensing Pact with Gilead for Lenacapavir

Dr Reddy’s inks voluntary licensing pact with Gilead to manufacture and commercialise lenacapavir in India and other countries

Overview

Dr Reddy’s Laboratories has entered into a royalty-free non-exclusive voluntary licensing agreement with Gilead Sciences Ireland UC for the manufacture and commercialisation of the drug, lenacapavir, in India and 120 other countries.

Lenacapavir: Approved for HIV-1

Lenacapavir is a United States Food and Drug Administration (FDA) approved drug indicated for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in heavily treatment-experienced adults with multidrug resistant HIV-1 infection failing their current antiretroviral regimen due to resistance, intolerance, or safety considerations.
Additionally, lenacapavir is currently under investigation for the prevention of HIV (PrEP) which is yet to be approved globally.

1st Launch of Lenacapavir

Gilead Sciences first launched lenacapavir under the brand name Sunlenca in the United States and Europe markets in the year 2022. It is a first-in-class HIV-1 capsid inhibitor.

Non-Exclusive Voluntary Licence to Dr Reddy

Dr Reddy’s has been granted a non-exclusive voluntary licence to manufacture lenacapavir and market it in 120 countries, for the current approved indication of HIV treatment in heavily treatment-experienced (HTE) adults with multi-drug resistant HIV.
Dr Reddy's will be responsible for technology transfer at its manufacturing site, conducting bioequivalence/clinical studies, product registration and launch in the agreed markets.
Additionally, the agreement grants licence to Dr Reddy’s to manufacture and commercialise lenacapavir for the indication of prevention of HIV (PrEP) in 120 countries, if approved.

Statement from Dr Reddy’s Laboratories

Deepak Sapra, chief executive officer- API and services, Dr Reddy’s Laboratories said: ""Lenacapavir marks an important milestone for Dr Reddy’s in patient access and affordability for pre and post exposure treatment of HIV.”
“The collaboration with Gilead will help us make this latest treatment option available to patients in 120 primarily low- and lower- middle income countries, including in India. Many of these countries have a very high disease burden of HIV. This is an important endeavour in our journey to create impact on 1.5 billion patients by 2030.”

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